Y-mAbs Therapeutics Inc.
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Public Company Edition: Also, Johnson & Johnson’s consumer health spin-out Kenvue filed paperwork to get the ball rolling on an initial public offering. In addition, Geron raised $198m and Madrigal accessed more than $300m after positive trial readouts, but layoffs were revealed by Editas, Elevation, Nabriva and others.
Advocates also worry that long follow-up times could prevent participation in future clinical trials.
Four of the six products up for a marketing authorization opinion from the EMA’s advisory committee, the CHMP, this week are orphan drugs. One of them, omburtamab, was recently turned down by a US FDA advisory panel.
The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.
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